Optical speculum

ABSTRACT

A system for direct imaging and diagnosing of abnormal cells in a target tissue includes a disposable optical speculum and an image acquisition system having the speculum assembled on and mechanically secured thereto. The image acquisition system is arranged to capture at least one of a single image or multiple images or video of cells within the target tissue using at least one of bright field or dark field ring illumination divided into independently operated segments to obtain a plurality of data sets. An image analysis and control unit in communication with the image acquisition system analyzes the data sets and applies algorithms to the data sets for diagnosing abnormal cells.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/186,735 filed Feb. 21, 2014, which is a continuation of U.S.application Ser. No. 14/030,088 filed Sep. 18, 2013, now U.S. Pat. No.9,259,157, which is a continuation of U.S. application Ser. No.12/943,170 filed Nov. 10, 2010, now U.S. Pat. No. 8,638,995 which, inturn, claims the benefit of U.S. provisional application Ser. No.61/259,663 filed Nov. 10, 2009, the disclosures of which are herebyincorporated in their entirety by reference herein.

TECHNICAL FIELD

This invention relates to an optical speculum, such as for use incolposcopy, gynecology examination, and detecting and/or removingabnormal cells.

BACKGROUND

Uterine cervical cancer is the second most common cancer in womenworldwide, with nearly 500,000 new cases and over 270,000 deathsannually. Colposcopy is a medical diagnostic method that is used todetect cervical intraepithelial neoplasia (CIN) and cancer, togetherwith a cytological screen (Papanicolaou smear; i.e., Pap smear).Colposcopy is a medical diagnostic procedure for viewing the cervix andthe tissues of the vagina and vulva, and is a common gynecologyprocedure following an abnormal Pap smear. A colposcope is a low poweredbinocular microscope with a light source, magnifying lens, and imagingsensor for viewing and inspection of internal cavities, and may includevideo.

Cervical cancer precursor lesions and invasive cancer exhibit certaindistinctly abnormal morphologic features that can be identified bycolposcopic examination. The purpose of this examination is to identifyand rank the severity of lesions, so that biopsies representing thehighest grade abnormality can be taken, if necessary. During theexamination, a 3-5% acetic acid solution is applied to the cervix,causing abnormal and metaplastic epithelia to turn white. A green filtermay be used to accentuate vasculature.

Today, the standard procedure for a gynecological exam invoices the useof a standard speculum with which the physician does a visualexamination of the interior vaginal cavity, without any control ofoptimal illumination or proper optical magnification, thus creating thepossibility of missing the detection of abnormal cells.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carriedout in practice, embodiments will now be described, the way ofnon-limiting examples only, with reference to the accompanying drawings,in which:

FIG. 1a is an assembly cross section view, including the inspectionarea, and including an example of a possible inspected area, the uterinecervix. 1100—Illustrates a cross section view of the upper part of theoptical disposable speculum; 1200—Illustrates a cross section view ofthe lower part of the optical disposable speculum; 1300—Illustrates across section view of the image acquisition system; 1500—Illustrates across section view of a possible inspected area, the uterine cervix.

FIG. 1b is an exploded view of the optical disposable speculum includinga lower part and an upper part. 1100—Illustrates the upper part of theoptical disposable speculum; 1200—Illustrates the lower part of theoptical disposable speculum.

FIG. 2a shows the design of the cover window in the lower part of theoptical disposable speculum-cross section view (1210). 1211—Illustratesthe front window lens area; 1212—Illustrates the snap area for the imageacquisition system; 1213—Illustrates a cut release for the operatingbuttons of the image acquisition system.

FIG. 2b illustrates the optical disposable front window lens-local view.1211—Illustrates the optical front window area; 1212—Illustrates thesnap area for the image acquisition system; 1222—Illustrates a linearcircular collimating lens for a dark field LED ring in the imageacquisition system; 1221—Illustrates an elastic layer of material forstray light blocking that may be caused by dark field illumination andbright field illumination; 1311—Illustrates dark field illumination LEDring.

FIG. 3a illustrates the image acquisition system-Outside view.1302—Image acquisition system body; 1303—Camera head operating buttons;1311—Dark field illumination LEDs ring.

FIG. 3b illustrates the image acquisition system-Inside view. 1311—Darkfield illumination LEDs ring; 1312—UV or IR LED illumination;1313—Bright field illumination LEDs ring; 1315—Imaging sensor area;1708—Dichroic mirror; 1340—Front group lens; 1320—Rear group lens.

FIG. 4 illustrates the illumination rays by showing a cross section viewof the SpeculuView system (optical disposable speculum assembled on theimage acquisition system). 1601—Dark field illumination rays;1602—Bright field illumination rays; 1312-Multi spectral (e.g., UV or IRLED) illumination; 1313—Bright field illumination LEDs ring.

FIG. 5a shows the optical design and chief rays for a one imagingsensor. 1701—Examined area; 1702—Chief return rays; 1703—Marginal returnrays; 1704—Window; 170—Meniscus element; 1706—Bi-concave element;1707—Bi-convex element; 1708—Dichroic Mirror; 1709—Aperture;1710—Plano-convex element; 1711—Meniscus element; 1712—Bi-convexelement; 1713—Beam Splitter; 1714—Bi-convex element to imaging sensor;1315—Color imaging sensor.

FIG. 5b shows the optical design and chief rays for a two imagingsensor. 1701—Examined area; 1702—Chief return rays; 1703—Marginal returnrays; 1704—Window; 1705—Meniscus element; 1706—Bi—concave element;1707—Bi-convex element; 1708—Dichroic mirror; 1709—Aperture;1710—Plano—convex element; 1711—Meniscus element; 1712—Bi-convexelement; 1713—Beam Splitter; 1714—Bi-convex element to imaging sensor(e.g., color sensor, monochrome sensor); 1715—Bi-convex element toimaging sensor (e.g., color sensor, monochrome sensor); 1315—Imagingsensor (e.g. color sensor, monochrome sensor).

FIG. 6a shows a schematic structure of the SpeculuView system: OpticalDisposable Speculum, Image Acquisition System modules, Image Analysisand Control Unit modules.

FIG. 6b illustrates the software initialization flow 1900. 1910—Imageacquisition system calibration (e.g., white balance) is a process ofdetermining the required amplification degree of the input signal,acquired by the sensor, which yields best image for analysis purposes;1920—Improper assembly detection, where the image analysis and controlunit verifies that the physician assembled and secured the opticaldisposable speculum in a correct manner; 1930—Interactive focus is amanual procedure which may be needed to be done by the physician forthis optical system design.

FIG. 6c illustrates image capture algorithm process flow 2000.2010—Selection light source type for image acquisition, wherein apossible light source may be UV and/or white light; 2020—Selection oflight mode: a continuous light or flashed illumination for differentillumination effects on the examined tissue for optimal detection;2030—Selection of illumination amplification for optimal imageacquisition; 2040—Determines the time span before the image isconsidered optimally illuminated for image acquisition; 2050—Acquiresthe image and analyzes it to verify if there are any changes needed foroptimal image acquisition and initiates image re—capture process.

FIG. 6d illustrates image analysis, display of suspicious areas bycontours and scoring algorithm.

FIG. 7 illustrates the image analysis and control unit. 2110—Illustratesthe box of control and analysis system; 2120—Illustrates the opticaldrive, read—write (e.g. DVD/+−RW, Blu-Ray/+−13 RW); 2130—Illustrates theOn/Off operating button; 2140—Illustrates the peripheral connection tothe camera head (e.g., USB); 2150—Illustrates the image acquisitioncable connector; 2160—Illustrates the LCD screen (e.g., touch LCD) forsystem function operation.

DETAILED DESCRIPTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention that may be embodied in variousand alternative forms. The figures are not necessarily to scale; somefeatures may be exaggerated or minimized to show details of particularcomponents. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for teaching one skilled in the art to variouslyemploy the present invention.

The invention, hereinafter the “SpeculuView” system, is an apparatuscomprising an optical disposable speculum, an image acquisition systemcomprising a treatment module and an image analysis and control unit.

The described system may be used as a colposcopy imaging system. It maycomprise a treatment module to apply an ablation technique of abnormalcells (e.g., cancerous cells) in the examined area (e.g., cervicaluterine).

One of the aims of the SpeculuView system is to assure detailedobservation with high resolution of objects located within a relativelywide area of the examined area (e.g., uterine cervix cavity), and enableaccurate ablation of abnormal cells (e.g., cancerous cells in theuterine cervix).

Low cost and high resolution colposcopy could have a direct impact onimproving women's health care, reducing examination costs and avoidanceof embarrassment. This low-cost hand-held image acquisition device canalso assist the expert colposcopist, and improve screeningcost-effectiveness in developing countries.

Colposcopy is the leading diagnostic method that is used to detectCervical Intraepithelial Neoplasia (CIN) and cancer, together withcytological screen (Papanicolaou smear—Pap Smear).

The purpose of a colposcopic examination is to identify and rank theseverity of lesions, so that biopsies representing the highest-gradeabnormality can be taken, if necessary. A green filter may be used toaccentuate vasculature. During the examination, a 3-5% acetic acidsolution is applied to the cervix, causing abnormal and metaplasticepithelia to turn white. Cervical cancer precursor lesions and invasivecancer exhibit certain distinctly abnormal morphologic features that canbe identified by colposcopy examination.

In the SpeculuView system, the optical disposable speculum is assembledon the image acquisition system on each examination. It protects thepatient from cross contamination. It creates a clean environment for theimage acquisition system, to prevent it from being contaminated (FIG. 1aand FIG. 1b ). This design enables a shortened time betweenexaminations.

There are two optional image acquisition designs presented herein: Asingle imaging sensor system comprised of a color CMOS or CCD (FIG. 5a )and an illumination system based on LEDs or LD (Laser Diode), and a dualimaging sensors system design comprised of two different CMOS orCCD-Color and monochrome (FIG. 5b ) and an illumination system based onLEDs or LD (Laser Diode).

The illumination system comprises bright field illumination 1313 (shownin FIG. 3b , FIG. 4), dark field external ring illumination 1311 (shownin FIG. 3a , FIG. 3b ), a UV LED source for fluorescence and orautofluorescence and/or a multi spectral source 1312 (e.g., white and orIR LEDs) (shown in FIG. 3b , FIG. 4).

The illumination system comprises UV LED source light for fluorescenceimage analysis in addition to bright and dark field white light sources.Based on previous research, abnormal cancerous cells are highlyemphasized by this kind of illumination. The optical design comprises adichroic mirror that transmits the light below 400 nm and reflects thelight above 440 nm. This beam splitter is well suited for suchfluorescence measurements.

In order to reach depth perception, there are three main features inthis system.

The system has the option for a large depth of field.

Using the contiguous zoom feature, the system can receive a sequence ofdifferent images of the same (X,Y) position at different focal planes.In this method, good perception of the inspected object depth can beattained.

The system applies dark field illumination in different angles using anexternal illumination ring element. As a non-limiting example, thesystem may be designed to divide and control the illumination ring(e.g., two sections). By use of one section of the ring in the firstimage and a second section of the ring in the second image the systemmay provide depth perception of the inspected object.

High resolution over the whole field is assured in order to insuredetection of all cancerous cells in one image.

Using these three methods the system can identify, for example, thetumor cell thickness, and its surface topology.

The image acquisition system is connected to the image analysis andcontrol unit (FIG. 7). The image analysis and control unit is a softwarepackage which may be implemented on special design hardware or astandard PC with custom hardware.

The image acquisition system may comprise an integrated laser ablationmodule for treatment of abnormal cells (e.g., cancerous cells in theuterine cervix).

The image acquisition system may acquire multi spectral images and/orlive video.

The image analysis and control unit automatically adjusts the intensityof each illumination mode independently (i.e., white (bright field andor dark field illumination), multi spectral illumination (e.g. UV and orIR)).

Data acquired from the examined area (e.g., uterine cervix) by the imageacquisition system is analyzed by the image analysis and control unitwhich provides tissue diagnosis. In case there are abnormal cells, theimage analysis and control unit identifies the suspicious regions whichshould be treated (e.g., cell ablation system).

In order to prevent stray light, the optical disposable speculum windowmay be designed with a layer of elastic material which creates afine-tuned coupling between the optical disposable speculum and theimage acquisition system. This design compensates the mechanical,manufacturing and assembly tolerances 1221 (shown in FIG. 2b ).

The optical disposable speculum may be coupled with an RFID (RadioFrequency Identification) unique tag. The image analysis and controlunit will assure the use of a brand new optical disposable speculum foreach patient per each examination. The RFID tag number is identifieduniquely by a serial number/lot number. The tag number which is coupledwith the optical disposable speculum will be specified in the patientexamination file. It can also assure the use of a brand new opticaldisposable speculum for each patient per each examination by snaps 1212which break after severance with the image acquisition system (shown inFIG. 3a ).

The image analysis and control unit is able to analyze white and/ormulti spectral images taken under the use of reflectance andauto-fluorescence reagents (i.e., contrast agents).

The image analysis and control unit is based on an open, modular, andfeature-based architecture. Analysis methods are designed for use withone or more imaging sensors, white and/or multi spectral illuminationtypes.

The image analysis and control unit may provide methods based on uniquealgorithms for accurate removal of abnormal cells (e.g., identifyingtheir margin).

The algorithm in the image analysis and control unit will create a mapof contours, namely edges between healthy and abnormal cells.

Reflectance and/or fluorescence images are acquired from the abnormalcells. Optionally, a short flash may acquire the reflectance and/orfluorescence images. Various reflectance and fluorescent images may beacquired under the same, or different, configurations of illumination.

Abnormal cells may be destroyed by ablation. The ablation procedure willbe operated automatic or by manual control of the set of adjustablemirrors controller that uses output indications of candidate abnormalcells. Upon completion of destruction by ablation, additionalreflectance or fluorescence images will be acquired to verify thecompletion of the procedure, resulting in no abnormal cells being left.

The laser ablation system may comprise an imaging sensor, flexible/solidoptical fiber, laser system, set of mirrors near the laser head and nearthe beam splitter which is located near the tip of the fiber, and anoptical system that will locally image the tested area. A long passfilter (e.g., GG475) may be located between the lens and the fibers inorder to subtract the Violet/UV light from the image for fluorescence.

The laser ablation system may be located in the area of the imagingsensors 1315 (shown in FIG. 3b ).

A pulsed laser beam is passed through a collimating optics, a set ofmirrors, a fiber bundle, another mirror, a beam splitter and secondfocusing optics. There are two optional places to use a motorizedadjustable set of mirrors. In the case where a straight solid fiberbundle is used, the laser beam location can be adjusted using themirrors near the laser, otherwise the adjustable steering mirror may bepositioned in front of the beam splitter near the edge of the fiberbundle and its tilted angles controlled remotely. This adjustable set ofmirrors receives a set of angles/travels as an output from the imageanalysis report or a set of points from the physician manually tomanipulate the orientation laser beam to selectively impinge on desiredlocations of malignant tissue to be destroyed.

The image analysis and control unit may use Picture Archiving andControl System (PACS) methods for image archiving and management.

Overcoming deficiencies of prior art colposcope systems, the systemaccording to the present invention provides:

An optical disposable speculum with a working channel for the physician

A small camera with multi spectral internal illumination systems:

Bright field LEDs (through the lens) illumination

Dark field LEDs illumination with a specific illumination angle

An internal UV illumination (“through the lens illumination”) forabnormal cell detection by fluorescence or auto fluorescence

An internal IR illumination (“through the lens illumination”)

An opportunity to examine with sufficient resolution fine objects at ashort distance with maximum patient protection

Optional In-Situ laser ablation of abnormal cells (e.g., cancerouscells)

The invention provides an optical disposable speculum that integrates alight collimation element guide for dark field illumination 1222 and anoptical window 1211 (shown in FIG. 2b ).

The optical disposable speculum may provide a working channel, and anadjustable locking mechanism for lower and upper speculum blades.

The working channel may be used for obtaining a Pap-Smear specimen, andpassing working tools (e.g., biopsy tools).

The invention separately provides an optical disposable speculum whichis a part of the whole optical design and is assembled on the imageacquisition system, thus providing a safe cross contamination protectionfor the examined patient.

The invention provides a high resolution imaging system which comprisesone or more imaging sensors, thus providing high dynamic range image.The importance of such information is that it can be used for computercalculation since such an image with high dynamic range is hard todisplay or print.

The invention separately may provide a system and methods including adetection algorithm for abnormal cell screening.

The invention may provide a special abnormal cell detection algorithmdesigned specifically for the uterine cervix.

The objective lens system of the image acquisition system may containtwo groups of optical components-group 1320 and group 1340 (shown inFIG. 3b ).

Group 1320 may include the aperture stop where the bright fieldillumination are components located, a group of optical components thatis connected to the imaging sensor and a beam splitter and or dichroicmirror. Group 1340 may include a group of optical elements with thedisposable optical window 1211 (shown in FIG. 2b ).

Between group 1320 and group 1340, in the image acquisition system, adichroic mirror 1708 (shown in FIG. 3b ) may be located to pass thebright field 1313 (e.g., white LED source illumination) (shown in FIG.3b ) with a beam splitter or a UV light source with the dichroic mirrorfor fluorescence or auto fluorescence (e.g., UV). The location of themulti spectral illumination and or the white/UV illumination source maybe on the other side of the dichroic mirror along the objective axis ofgroup 1340.

The optical system may comprise a design of an optical zoom lens systemalong the optical axis, or a discrete zoom design perpendicular to theoptical axis (e.g., slider design).

The image acquisition system is an electro optical element whichfunctions as an integrated system for multi spectral imaging andtreatment. The image acquisition system is locked to the opticaldisposable speculum with a releasable secured mechanical lock.

This invention provides a system and methods for high resolution imagingof the examined area (e.g., uterine cervix). The system provides imageanalysis for tissue abnormalities.

The invention may be used as an image analysis for tissue abnormalitiessuch as cervical intraepithelial neoplasia (CIN) or invasive cancer.

The system control and analysis unit provides a real time image or livevideo that is acquired from the examined area. It provides tissuediagnosis and it may provide the ability to ablate, in an accuratemanner, the abnormal cancerous cells. Images or live video and analysisresults are displayed both to the physician and patient.

The system control and analysis unit may acquire real time images orlive video from the uterine cervix. It may ablate, in an accuratemanner, the abnormal cancerous cells in the uterine cervix.

The invention provides an assembly verification process (e.g., imagingalgorithm) of the assembled optical disposable speculum to the imageacquisition system.

The imaging acquisition system acquires color and/or monochrome images.The acquired data of the examined area is analyzed by the image analysisand control unit. The image and analysis control unit outputs agraphical representation of suspicious regions and classification of thedetected tissue.

The imaging acquisition system may acquire color and/or monochromeimages from the uterine cervix.

FIGS. 5a and 5b schematically illustrate an optical design for use in anoptical head of an image acquisition system for viewing internalcavities (e.g., uterine cervix).

The image acquisition system may be used for video laparoscopy by usinga special optical adapter assembled on the image acquisition system.

The image acquisition system and the image and analysis control unit maybe used for detection of abnormal cells in a laparoscopy procedure.

In FIG. 5a , an optional meniscus lens 1705 comprising a first frontoptical component of the system may be located in the optical disposablespeculum.

In FIG. 5a , a front sub optical system is shown comprising a set oflenses as follows: meniscus 1705, Bi-concave 1706 and Bi-convex 1707.

In FIG. 5a , a rear sub optical system is shown comprising a set oflenses as follows: aperture 1709, plano-convex element 1710, meniscuselement 1711, Bi-convex element 1712, beam splitter 1713, Bi-convexelement 1714.

In FIG. 5a , at the end of the optical apparatus the imaging sensors1315 (e.g., CCD or CMOS) are located for image capture.

In FIG. 5b , an optional meniscus lens comprising a first front opticalcomponent of the system 1705 is shown.

In FIG. 5b , a front sub optical system is shown comprising a set oflenses as follows: meniscus 1705, Bi-concave 1706 and Bi-convex 1707.

In FIG. 5b , a rear sub optical system is shown comprising a set oflenses as follows: aperture 1709, plano-convex element 1710, meniscuselement 1711, Bi-convex element 1712, beam splitter 1713, Bi-convexelement 1714 to color or monochrome imaging sensors 1315 (e.g., CCD orCMOS), Bi-convex element 1714 to color or monochrome imaging sensors1315.

In FIG. 5b , at the end of the optical apparatus, the imaging sensors1315 are located for image capture.

The optical design may comprise a motor along the optical system axismoving another optical component or components creating optical zoom andfocus correction.

The optical design may comprise a motor, perpendicular to the opticalsystem axis moving another optical component or components, with two ormore stages. The sliding mechanism replaces an intermediate component orcomponents, thus creating a discrete optical magnification.

On initialization, it is required to go through sensor self-calibration(e.g., white balance). This procedure calibrates the image sensor withinternal parameters set for optimal image capture. Image capturing whileusing these parameters by the sensor avoids unrealistic color or graylevel in the final captured image under certain illumination setups(type, mode, etc.) and improves the captured image under a wider rangeof illumination conditions.

On initialization, the image analysis and control unit initializes theimage acquisition system. The image acquisition system starts aself-calibration procedure (e.g., white balance) which avoidsacquisition of unrealistic color or gray level. It is the system controland analysis system which responsible for controlling the imageacquisition system under certain illumination settings and given tissueconditions (e.g., under use of reflectance reagents).

The module involves activation of the illumination source in the workinglimits within the dynamic range of the system, and recognition of straylight which will indicate that the optical disposable speculum is notproperly mounted (FIG. 6b ). This module may be identified as: “StrayLight Detection Module” (SLDM).

There are two possible option of focusing:

Option 1: A fixed lens mechanical design that requires an optimallocation positioning procedure. It is the physician who guides theoptical disposable speculum with the camera head installed in front ofthe examined area (e.g., uterine cervix) and activates a fine tuningpositioning process. In the optimal location positioning procedure, theimage analysis and control unit continuously grabs images and producesfocus results, which recommend to the physician to make finalpositioning corrections (FIG. 6b ).

Option 2: When using a non-fixed lens mechanical design, an automaticfocus mechanism sets an optimal location of the lens. It is thephysician who guides the optical disposable speculum with the camerahead installed in front of the examined area (e.g., uterine cervix) andactivates a fine tuning focus positioning process. In the optimallocation positioning procedure, the image analysis and control unitcontinuously grabs images and produces the best focus results.

There are two main image capture modes. Manual mode requires thephysician to control the illumination parameters before the image isacquired and delivered for final analysis. Automatic mode does notrequire any intervention of the physician with respect to theillumination configuration. An optimal image capture parametersadjustment algorithm continuously grabs images while changing the valuesof illumination type, mode, intensity and exposure time in order toproduce an optimal image for analysis (FIG. 6b ).

A numerical analysis for autofluorescence imaging for pathologicaltissue detects a cancerous area in a given image. The numerical analysisfor auto fluorescence imaging includes a pathological tissue algorithmthat uses the special characteristics of the reflected ultraviolet lightsource. The numerical analysis for autofluorescence imaging forpathological tissue detects and renders suspicious regions in a givenimage, and generates a pathological lesion scoring for the region.

While exemplary embodiments are described above, it is not intended thatthese embodiments describe all possible forms of the invention. Rather,the words used in the specification are words of description rather thanlimitation, and it is understood that various changes may be madewithout departing from the spirit and scope of the invention.Additionally, the features of various implementing embodiments may becombined to form further embodiments of the invention.

What is claimed is:
 1. A system for direct imaging, diagnosing andremoving of abnormal cells in a target tissue, comprising: a disposableoptical speculum which integrates a light collimation element guide fordark field illumination with an optical window; an image acquisitionsystem having the speculum assembled on and mechanically securedthereto, the image acquisition system arranged to capture at least oneof a single image or multiple images or video of cells within the targettissue using separate monochrome and color sensors having a commonoptical path with at least one of bright field or dark field ringillumination divided into independently operated segments to obtain aplurality of data sets; and an image analysis and control unit incommunication with the image acquisition system, the image analysis andcontrol unit analyzing the data sets and applying algorithms to the datasets for diagnosing abnormal cells.
 2. The system according to claim 1,wherein the disposable optical speculum covers an optical head and yetenables a free working channel for taking a manual biopsy.
 3. The systemaccording to claim 1, wherein the image acquisition system includes oneor more high resolution imaging sensors which capture differentwavelength images of a whole field of the target tissue, wherein theimages are injected into separate channels of the image analysis andcontrol unit and presented separately on a screen.
 4. The systemaccording to claim 1, wherein the optical disposable speculum isdesigned for single use to protect from cross-contamination and theimage acquisition system is designed for multiple uses.
 5. The systemaccording to claim 1, wherein the image acquisition system furthercomprises a laser ablation module with a 2-D tilted mirror system toenable accurate ablation of abnormal cells, wherein the laser ablationmodule uses the data sets to eliminate the diagnosed abnormal cells, andthe image acquisition system is designed to stop ablation when it isdetected that abnormal cells no longer exist in the image.
 6. The systemaccording to claim 5, wherein the laser ablation module comprises anInfra Red/Green/Ultra Violet short pulse laser beam guided via a highpower fiber to the target tissue using an imaging lens for focusing thepulse beam with enough pulse energy and pulse peak power to remove theabnormal cells.
 7. The system according to claim 1, wherein the opticalwindow is provided with a layer of elastic material which creates acoupling between the optical disposable speculum and the imageacquisition system to prevent stray light.
 8. The system according toclaim 1, further comprising a locking mechanism between the opticaldisposable speculum and the image acquisition system to assure imageacquisition without distortions.
 9. The system according to claim 1,wherein the image acquisition system further comprises a zooming lensthat can be implemented by using a miniature piezo or electric motor.10. The system according to claim 1, wherein the image acquisitionsystem further comprises at least one of automatic, semi-automatic andmanual illumination LEDs and a laser diode (LD) adjustment.
 11. Thesystem according to claim 1, wherein the image acquisition systemcomprises one of a single or dual sensor imaging system with color andmonochrome CMOS or CCD, and an illumination system based on one of LEDsor laser diode (LD).
 12. The system according to claim 11, wherein theillumination system comprises bright field illumination, dark fieldexternal ring illumination, and one of a UV LED source for fluorescenceor autofluorescence or a multi-spectral source.
 13. The system accordingto claim 11, wherein the illumination system includes a ring ofwhite/monochromatic LEDs positioned near a lens aperture in order tooptimize the delivery of light into the target tissue with minimum angleof incidence to optimize the reflection from the tissue using a secondpart of an objective lens.
 14. The system according to claim 1, whereinthe image acquisition system achieves depth perception in an acquiredimage by using at least one of a large depth of field, a contiguous zoomfeature to receive a sequence of different images of the same X,Yposition at different focal planes, and dark field illumination appliedat different illumination angles using a ring external illuminationsystem.
 15. The system according to claim 1, wherein the imageacquisition system includes a camera apparatus comprising a camera, alens attached to the camera, and a long pass filter which will subtractthe UV/near UV light in order to obtain a fluorescence image.
 16. Thesystem according to claim 10, wherein the illumination system includes alight source having one of an external strobe or camera electronicshutter to control the camera exposure time and prevent any saturationin the imaging system.
 17. The system according to claim 1, furthercomprising a detector for warning of undesired stray light generated byimproper assembly of the optical disposable speculum to the imageacquisition system.
 18. The system according to claim 1, wherein eachoptical disposable speculum includes an RFID tag to provide a uniqueidentification for each optical disposable speculum and ensure use of anew optical disposable speculum when desired.
 19. A system for directimaging, diagnosing and removing of abnormal cells in a target tissue,comprising: a disposable optical speculum which integrates a lightcollimation element guide for dark field illumination with an opticalwindow; an image acquisition system having the speculum assembled on andmechanically secured thereto, the image acquisition system arranged tocapture at least one of a single image or multiple images or video ofcells within the target tissue using at least one of bright field ordark field ring illumination divided into independently operatedsegments to obtain a plurality of data sets, wherein the imageacquisition system achieves depth perception in an acquired image byusing a contiguous zoom feature to receive a sequence of differentimages of the same X,Y position at different focal planes; and an imageanalysis and control unit in communication with the image acquisitionsystem, the image analysis and control unit analyzing the data sets andapplying algorithms to the data sets for diagnosing abnormal cells.